Patient NAVIgation to Reduce Readmissions Among Black Men With Heart Disease
NAVI-HF
1 other identifier
interventional
301
1 country
2
Brief Summary
The investigators are asking subjects to take part in the Patient NAVIgation to Reduce Readmissions among Black Men with Heart Disease (NAVI-HF) research study. This research study will test how well trained laypeople working as patient navigators will help patients recently hospitalized for heart failure avoid future hospitalizations. NAVI-HF is a new program sponsored by funding from the National Institute of Minority Health and Health Disparities. People who enter into the study will work with a patient navigator to undergo the full program or work with a trained layperson to receive general education on heart disease treatment and prevention. The purpose of the study is to determine whether a patient navigation program will be effective in reducing the number of hospitalizations in the future for program participants. This study will enroll 416 participants from UAB.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2015
CompletedFirst Posted
Study publicly available on registry
January 16, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedJuly 31, 2019
July 1, 2019
4.3 years
January 13, 2015
July 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Readmission Rates
Re-hospitalization of Heart Disease patients within 30 days of being discharged home.
Within 30 days
Study Arms (2)
Education + PN Arm
EXPERIMENTAL208 patients randomized to self-care education+ Patient navigator-delivered self-care plan.
Educational Control Arm
ACTIVE COMPARATOR\- 208 patients randomized to self-care education alone.
Interventions
208 patients randomized to self-care Education+ Patient Navigation-delivered self-care plan.
208 patients randomized to self-care education alone.
Eligibility Criteria
You may qualify if:
- African American
- Male
- Age = 30 or older
- Inpatient admission at UAB Hospital or UAB Medical West with a diagnosis of heart disease as a principle or one of the first 3 diagnosis.
- Residence in Jefferson or Shelby Counties, Alabama within 45 miles of UAB Hospital.
- English Speaking
- Physically and cognitively able to listen to 30-minute video undergo a home visit and telephone contacts over several weeks.
You may not qualify if:
- Heart transplant or awaiting heart transplant (admitted to UAB Advanced HF/Transplant Service).
- Currently participating in another clinical research study with an overlapping intervention.
- Current or anticipated long term (\>2 weeks) residence in a skilled nursing facility.
- Patients who indicated that they were unwilling to make lifestyle changes now or in the near future.
- Patients whose symptoms may be eliminated by surgery (e.g., severe aortic stenosis) or who had undergone surgery (e.g., coronary artery bypass grafting valvular replacement/repair) in the last month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UAB Medical West
Bessemer, Alabama, 35022, United States
UAB
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raegan W Durant, M.D., MPH
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 13, 2015
First Posted
January 16, 2015
Study Start
March 1, 2015
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
July 31, 2019
Record last verified: 2019-07